IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G— 510(k) K884074

Name: FDA 510(k) clearance K884074
Creator: U.S. Food and Drug Administration
Published: 1988-10-27

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K884074 for IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G, Substantially Equivalent on 1988-10-27. Applicant: Orion Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code DAH
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1988-09-27
Decision date: 1988-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 02101 Espoo, FI

Download summary PDF View on FDA.gov ↗

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